Brammer Bio, a leading cell and gene therapy contract developing and manufacturing organization (CDMO), has confirmed expansions in its early clinical phase facility in Alachua, Florida and its new Phase III and commercial facility in Cambridge, Massachusetts. The CDMO is currently making enhancements worth $40M to enable scale-up through Phase III and strengthen commercial client support in Cambridge. At Alachua's process development and pilot facility, Brammer invested $10M to double cGMP manufacturing capacity. Both sites will feature Pall Life Sciences enabling technologies for efficient cell and gene therapy manufacturing.
"Since launching in early 2016, our team has rapidly grown to 300, and now we are focused on expanding much-needed capacity for customers. During planning and evaluation phases, Pall Life Sciences was selected as a preferred technology partner for the design, ease of use, and results achieved with Pall's process equipment," said Richard Snyder, chief scientific officer at Brammer Bio. "With Pall's critical process solutions and process support, we look forward to building on more than 100 executed projects and 150 clinical cell and gene therapy lots in Florida—including many first-in-human trials—and 600 plus commercial biologics batches produced in Massachusetts."
Brammer Bio is implementing a range of advanced Pall platform technologies, with AllegroTM STR single-use stirred-tank bioreactors for cell culture capability up to 500L in Alachua, and up to 2,000L in Cambridge. Both facilities will feature iCELLis® fixed-bed bioreactors for efficient scale-up of adherent processes with up to 5,000 square feet of growth surface, Allegro XRS 25 bi-axial rocking bioreactors, and a variety of Pall single-use mixers. The downstream purification suite will feature Pall's state-of-the-art, single-use tangential flow filtration (TFF) systems, Allegro MVP systems for fluid automation, and Allegro single-use chromatography systems.
"This partnership shows our ability at Pall to deliver an end-to-end single-use platform solution from upstream to downstream," said Mario Philips, vice president and general manager of Pall Biotech. "It is an honor to have our technologies selected by companies like Brammer Bio, as they work on the next-generation of novel medicines."
Both facilities remain operational during the expansions, with the Florida expansion now online, and completion of the Cambridge facility targeted for Q4 2017. For facility inquiries or more information on working with Brammer Bio, please contact firstname.lastname@example.org or 1.877.GENECMO (436.3266), or visit www.brammerbio.com.
To learn more about Pall Life Sciences total solutions product and services portfolio, please visit: www.pall.com/biopharm. To start a direct conversation, please email email@example.com. Or, find Pall Life Sciences biopharmaceutical division on social media: LinkedIn – Twitter – YouTube
About Brammer Bio
Brammer Bio is a leading CDMO providing clinical and commercial supply of vectors for in vivo gene therapy and ex vivo modified-cell based therapy, process and analytical development, and regulatory support, enabling large pharma and biotech clients to accelerate the delivery of novel medicines to improve patient health. Brammer is owned by Ampersand Capital Partners, the only institutional investor in the company, and its founders. For more information, please visit www.brammerbio.com.
About Pall Corporation
Pall Corporation is a filtration, separation and purification leader providing solutions to meet the critical fluid management needs of customers across the broad spectrum of life sciences and industry. Pall works with customers to advance health, safety and environmentally responsible technologies. The company's engineered products enable process and product innovation and minimize emissions and waste. Pall Corporation serves customers worldwide.